Events

Recall of BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PHILIPS ELECTRONICS LTD..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56860
  • Event Risk Class
    III
  • Event Initiated Date
    2012-08-31
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Philips healthcare received a complaint stating the system opens e-stop while sitting idle causing all movements and scan to stop. the problem has only occurred one time when the scan was out of "ready for scan" or scanning mode.

Device

BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 4535 670 88051 (Lot serial: 7565); Model Catalog: 4535 670 88051 (Lot serial: 7509); Model Catalog: 4535 670 88051 (Lot serial: 7497); Model Catalog: 4535 670 88051 (Lot serial: 7379); Model Catalog: 4535 670 88051 (Lot serial: 7489); Model Catalog: 4535 670 88051 (Lot serial: 7431); Model Catalog: 4535 670 88051 (Lot serial: 7403); Model Catalog: 4535 670 88051 (Lot serial: 7493)
  • Product Description
    BRILLIANCE CT BIG BORE SYSTEM - MAIN UNIT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC